Randomised controlled trial to compare the effects of granulocyte-colony stimulating factor (G-CSF) and autologous bone marrow progenitor cells infusion on quality of life and left ventricular function in patients with heart failure secondary to ischaemic heart disease

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN68837678
• Date of registration: 23/11/2005
• Prospective Registration: No
• Primary sponsor: Barts and the London NHS Trust (UK)
• Public title: Randomised controlled trial to compare the effects of granulocyte-colony stimulating factor (G-CSF) and autologous bone marrow progenitor cells infusion on quality of life and left ventricular function in patients with heart failure secondary to ischaemic heart disease
• Date of first enrolment: 18/05/2005
• Target sample size: 300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN68837678
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Anthony Mathur

Key inclusion & exclusion criteria

Inclusion criteria: Patients with a diagnosis of heart failure secondary to ischaemic heart disease attending a heart failure clinic for optimisation of their heart failure medication or who are on optimal heart failure treatment under supervision from their physician.
Exclusion criteria: 1. Recent acute coronary sydrome as judged by a rise of troponin above normal values in the last 6 months
2. The presence of cardiogenic shock
3. The presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
4. Known severe pre-existent left ventricular dysfunction (ejection fraction <10% prior to randomisation)
5. Congenital cardiac disease
6. Cardiomyopathy secondary to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity and chronic uncontrolled tachycardia
7. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
8. Contra-indication for bone marrow aspiration
9. Known active infection
10. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
11. Lifestyle with high risk for infection with HIV, HBV, or HCV
12. Chronic inflammatory disease
13. Serious known concomitant disease with a life expectancy of less than one year
14. Follow-up impossible (no fixed abode etc.)
15. Previous participation in this study
16. Female subjects of childbearing potential
17. Paced rhythm >80% of the time
18. Serum creatinine >200 mg/dl

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Heart failure secondary to ischaemic heart disease.
Circulatory System
Heart failure

Intervention(s)

Daily subcutaneous injections of G-CSF at 10 µg/kg or placebo OR daily subcutaneous injections of G-CSF at 10 µg/kg followed by intracoronary injection of stem cells or placebo OR daily subcutaneous injections of G-CSF at 10 µg/kg followed by intramyocardial injection of stem cells or placebo

Primary Outcome(s)

At 6 months:
1. The change in global left ventricular ejection fraction (LVEF) at 6 months relative to baseline measured by quantitative left ventriculography
2. The change in regional wall motion score index at 6 months relative to baseline measured by tissue doppler imaging
3. The change in quality of life scores compared to baseline

Secondary Outcome(s)

At 6 months:
1. Death as result of the underlying cardiac condition
2. The occurence of major arrhythmias defined as ventricular tachycardia or survived sudden death
3. Presence of clinically evident heart failure
4. The change in global left ventricular ejection fraction at 6 months relative to baseline measured by resting echocardiography
4. The change in global and regional wall motion score index measured by resting echocardiography
5. Serum levels of amino-terminal pro-brain natriuretic peptide (NT-BNP)
6. Change in myocardial function as measured by magnetic resonance imaging (MRI) scanning (first 40 suitable patients in each group)
7. Change in voltage and shortening maps as assessed by NOGA (intramyocardial group only)

At 12 months:
1. The occurrence of a major adverse cardiac event (MACE)
2. The change in left ventricular ejection fraction relative to baseline measured by resting echocardiography using Simpson's rule
3. The change in global and regional wall motion score index measured by resting echocardiography and tissue doppler imaging
4. Change in quality of life scores
5. Serum levels of amino-terminal pro-brain natriuretic peptide (NT-BNP)
5. Change in myocardial function as measured by MRI scanning (first 40 suitable patients in each group)

Secondary ID(s)

1.2

Source(s) of Monetary Support

The Heart Cells Foundation